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OpenTrials
Completed

NCT Number: NCT06993311

Real World Evidence of Xen45 Gel Implant in Pseudoexfoliation Glaucoma

The Xen implant is an ab interno device that has been shown to be effective in reducing intraocular pressure in several types of glaucoma, although the evidence in pseudoexfoliative glaucoma is limited. The present retrospective observational study aims to increase knowledge about the long-term effectiveness and safety of the implant in pseudoexfoliative glaucoma. Researchers will compare the results with data from patients with open-angle glaucoma.

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Key information

Conditions

Pseudoexfoliation Syndrome Exfoliation Syndrome Eye Diseases Glaucoma Glaucoma, Open-Angle Iris Diseases Ocular Hypertension Open Angle Glaucoma Pseudoexfoliation Glaucoma in Both Eyes Uveal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Sara Pose-Bazarra

Ferrol, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Data will be collected for all patients with pseudoexfoliation glaucoma (PXFG), ocular hypertension (OHT) and pseudoexfoliation syndrome, POAG and other secondary open angle glaucoma (OAG) diagnosed, who underwent surgery from 2018 to 2022.

Patients should be candidates for filtering glaucoma surgery for the following indications:

  • uncontrolled intraocular pressure (IOP)
  • intolerance or non-adherence to topical treatment
  • glaucoma progression despite topical therapy
  • surgical cataract patients undergoing phacoemulsification, who were treated with two or more hypotensive drugs and wished to withdraw the medication due to side effects and/or discomfort of the treatment.

Refractory glaucoma and eyes with previous filtering surgery, previous laser treatments or micropulse transscleral cyclophotocoagulation will be also included.

Exclusion criteria

  • Patients with follow up less than 12 months.
  • Patients with end-stage glaucoma, uveitic and angle closure glaucoma.

Treatment and study plan

Xen Gel Stent implantation

Device

Consecutive patients who underwent either stand-alone Xen stent insertion with MMC(mitomycin C) or combined phacoemulsification between 2018 and 2022

Primary outcomes

  1. INTRAOCULAR PRESSURE

    Time frame: 12-48 months

    The primary outcome measure will be intraocular pressure reduction at final follow up

Secondary outcomes

  1. NUMBER OF TREATMENTS

    Time frame: 12-48 months

    Number of glaucoma drugs: Investigate the reduction of drugs after surgery

  2. BEST CORRECTED VISUAL ACUITY

    Time frame: 12-48 months

    Best-corrected visual acuity (BCVA): investigators will compare the change of visual acuities (VA) between pre-surgery to last follow-up

  3. RETINAL NERVE FIBER LAYER

    Time frame: 12-48 months

    Retinal nerve fiber layer (RNFL) thickness by optical coherence tomography (OCT): investigators will compare the reduction in the retinal nerve fiber layer by OCT according to the analysis of glaucoma (Heidelberg)

  4. RATES OF REINTERVENTION

    Time frame: 12-48 months

    Number of trabeculectomy or filtering surgery required as a result of poor control of IOP

  5. INCIDENCE OF TREATMENT ADVERSE EVENTS

    Time frame: 12-48 months

    Investigators will determine the safety profile of the intervention through an evaluation of intraoperative and post-operative complications. All adverse events or complications related to the intervention will be recorded in a descriptive manner.

  6. PRESERVATIVES EXPOSURE

    Time frame: 12-48 months

    Investigators will collect data on pre-surgery treatment regarding the use or non-use of preservatives and their exposure time to these drugs to compare effectiveness outcomes in both groups.

Sponsors and collaborators

Lead sponsor

Xerencia de Xestión Integrada de Ferrol

Other

Collaborators

  • University Hospital Complex of Santiago de Compostela

Registry information

Official study title

Four-year Outcomes of Minimally Invasive XEN Gel Stent Implantation in Pseudoexfoliation Glaucoma: Real World Evidence

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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